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Intranasal Treatment of HIV-associated Neurocognitive Disorders

9. juni 2020 opdateret af: John Gill, University of Calgary

HAND IN Insulin-001: Intranasal Treatment of HIV-associated Neurocognitive Disorders

This study aims to see whether intranasal insulin is an effective treatment for problems with memory, concentration, slowed thinking, or any other cognitive function in people living with HIV/AIDS. This group of signs and symptoms are called 'HIV-associated neurocognitive disorders' or HAND. HAND can affect people living with HIV/AIDS even when they receive potent anti-HIV treatments. Treatment of HAND by specific medication or other means is not yet available. Intranasal insulin treatment has virtually no side-effects, and has already been tested in people with Alzheimer's disease, where it showed beneficial effects on memory, mood and quality of life

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study is designed as a prospective, double-blinded pilot study of intranasal (IN) insulin versus placebo in people with HAND (n = 20) on stable ART medication. Participants will be randomly assigned to one of two groups: 40 IU IN insulin R twice daily, or matched-volume placebo, which will be administered twice daily, taken after breakfast and again after dinner using a nasal delivery device. Serum glucose will be tested for hypoglycemia one hour after the initial administration of IN insulin or placebo and after administration at Weeks 1, 2, and 3. If the dose is tolerated and no side effects are reported the participant will continue in the study. If the dose is not tolerated due to hypoglycemia then the participant will be withdrawn from the study.

The objectives of this study are as follows:

Primary: Determine if IN insulin treatment administered twice daily for 4 months reduces overall neurocognitive deficits (based on the global z-score in people with HAND).

Secondary: Measure effects of IN insulin on individual neuropsychological domains (e.g., memory, processing speed, executive functions, motor functions) and on HAND disease progression; Define impacts of IN insulin on quality of life and mood in people with HAND; Investigate IN insulin's effects on HAND biomarker profiles in urine and blood.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

4

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2R 0X7
        • Southern Alberta Clinic

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Documented HIV-1 infection
  • Maintained on stable ART for ≥6 months (defined as undetectable viral load)
  • HAND-MND or -ANI diagnosis with evidence of clinical onset or progression within the prior 2 years, based on established criteria
  • Currently followed at the Southern Alberta Clinic (SAC; Calgary, AB, Canada)

Exclusion Criteria:

  • HAND with a) changed dose of any medication for HIV-1 infection with a corresponding increase in viral load (e.g., ART), or b) secondary therapies for HAND (e.g., memantine, amphetamines).
  • Advanced liver, renal or lung disease, cancer or diabetes requiring insulin
  • Secondary diagnosis of neurocognitive impairment or other major neuropsychiatric illness such as epilepsy, Alzheimer's or Parkinson's diseases, major depression (PHQ-9 score >10), or schizophrenia
  • Central nervous system lesion (diagnosed by neuroimaging) that may impair cognition
  • Previous allergic reaction to insulin or any of the carrier components.
  • Education < 9 years or inability to read and write English fluently
  • Uncontrolled HIV-1 or hepatitis C co-infection
  • Inability to perform NP or questionnaire measures, functional illiteracy
  • Past or current substance abuse that could interfere with the study assessments as determined by the PI
  • Marijuana use on the day of NP testing
  • Uncontrolled cardiovascular disease (hypertension, coronary or peripheral artery disease)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: IN insulin 40 IU
Drug: IN insulin Dosage form: intranasal Dose: 40 IU Frequency: bid Duration: 16 weeks
Biologisk: IN insulin
IN insulin twice daily taken after breakfast and again after dinner using the nasal delivery device.
Andre navne:
  • Intranasal Humulin R
Placebo komparator: IN Sterile Saline
Drug: Sterile Saline Dosage form: intranasal Frequency: bid Duration: 16 weeks
Biologisk: Sterile Saline placebo
Sterile Saline placebo twice daily taken after breakfast and again after dinner using the nasal delivery device.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Global Neurocognitive Performance from Baseline
Tidsramme: 18 weeks
Change in overall neurocognitive function as measured by the global z score. The global z score is one measurement calculated as the average of z scores from each domain tested.
18 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline in Neurocognitive Performance: Memory
Tidsramme: 18 weeks
Change from baseline in the overall z score for the memory domain, calculated as the average of z scores from: Hopkins Verbal Learning Test, Logical Memory Test, and Brief Visual Memory Test (immediate and delayed recall).
18 weeks
Change from Baseline in Neurocognitive Performance: Executive Function
Tidsramme: 18 weeks
Change from baseline in the overall z score for the executive function domain, calculated as the average of z scores from: D-KEFS Trail-making Task (Letter-Switching) and Color-Word Interference (Stroop).
18 weeks
Change from Baseline in Neurocognitive Performance: Attention
Tidsramme: 18 weeks
Change from baseline in the overall z score for the attention domain, calculated as the average of z scores from: Symbol Digit Modalities Test, D-KEFS Trail-making Test (Number), and Color-Word Interference (Color and Word Reading).
18 weeks
Change from Baseline in Neurocognitive Performance: Motor Function
Tidsramme: 18 weeks
Change from baseline in the overall z score for the motor function domain, calculated as the average of z scores from: grooved pegboard completion times for dominant and non-dominant hands.
18 weeks
Change from Baseline in Neurocognitive Performance: Language
Tidsramme: 18 weeks
Change from baseline in the overall z score for the language domain, calculated as the average of z scores from: D-KEFS Letter and Category Verbal Fluency Tasks
18 weeks

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in HQoL questionnaire score
Tidsramme: 18 weeks
Change from baseline in health-related quality of life (HQoL) questionnaire score
18 weeks
Change from baseline in the PHQ-9 Questionnaire score
Tidsramme: 18 weeks
Change in the Patient Health Questionnaire-9 (PHQ-9) depressive symptoms score.
18 weeks
Change from Baseline in the Frailty Index Score - questionnaire and clinic assessment
Tidsramme: 16 weeks
Change in the overall Frailty Index score measured from baseline to Week 8.
16 weeks
Change from Baseline HAND inflammasome biomarker laboratory result profile
Tidsramme: 16 weeks
Change in inflammasome biomarker laboratory result profile between baseline and week 16.
16 weeks
Change from Baseline HAND metabolomics biomarker laboratory result profile
Tidsramme: 16 weeks
Change in metabolomics biomarker laboratory result profile between baseline and week 16.
16 weeks
Change from Baseline plasma HIV-1 viral load laboratory result
Tidsramme: 16 weeks
Change in plasma HIV-1 viral load between baseline and week 16.
16 weeks
Change from Baseline blood CD4 T-cell count laboratory result
Tidsramme: 16 weeks
Change in blood CD4 T-cell count between baseline and week 16.
16 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Calgary

Samarbejdspartnere

Canadian Institutes of Health Research (CIHR)
University of Alberta
Epidemiology Coordinating and Research Centre, Canada

Efterforskere

  • Ledende efterforsker: Christopher Power, MD, FRCPC, University of Alberta
  • Ledende efterforsker: Michael J Gill, MBChB FACP, University of Calgary

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. november 2018

Primær færdiggørelse (Faktiske)

21. april 2019

Studieafslutning (Faktiske)

21. april 2019

Datoer for studieregistrering

Først indsendt

28. august 2017

Først indsendt, der opfyldte QC-kriterier

6. september 2017

Først opslået (Faktiske)

8. september 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juni 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juni 2020

Sidst verificeret

1. juni 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • REB17-0104
  • Control# 204512 (Anden identifikator: Health Canada)

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Kliniske forsøg med HIV-associeret neurokognitiv lidelse (HAND)

Kliniske forsøg med IN insulin

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